FDA Launches ImportShield Program to Strengthen Oversig…
On January 21, 2026, the U.S. Food and Drug Administration (FDA) announced the launch and initial results of the FDA ImportShield Program (F…
Read more
Indonesia Ministry of Trade Introduces Import Ban on Su…
On January 2, 2026, Indonesia’s Database of Legislation published a new Ministry of Trade regulation that introduces a ban on the importat…
Read more
UK MHRA Updates Guidance on Determining Borderline Prod…
On 17 October 2025, the Medicines & Healthcare products Regulatory Agency (MHRA) published updated guidance on borderline products, clar…
Read more
US FDA Announces Deployment of Agentic AI Capabilities …
On December 1, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of new agentic AI capabilities to enhance pre-mark…
Read more
HSA Singapore Issues Updated Guidance on Medical Device…
On 5 November 2025, the Health Sciences Authority (HSA) of Singapore released new guidance documents outlining regulatory requirements for m…
Read more
U.S. Launches Investigation into Medical Device and PPE…
On September 26, 2025, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) announced a Section 232 investigation into …
Read more
FDA Launches Regulatory Accelerator to Boost Medical De…
FAQs What is the FDA’s Regulatory Accelerator? The Regulatory Accelerator is an initiative launched by the FDA on 24 July 2025 to suppor…
Read more
The Future of RegTech in Medical Devices & SaMD: 8…
Emerging technologies like artificial intelligence, predictive analytics, and blockchain are redefining how medical devices and Software as …
Read more
FDA Launches “Elsa”: Agency-Wide Generative…
On June 2, 2025, the U.S. Food and Drug Administration (FDA) officially launched Elsa, a generative artificial intelligence (AI) tool develo…
Read more
ANVISA Publishes Preliminary Manual for Brazil’s UDI …
ANVISA Publishes Preliminary Manual for Brazil’s Unique Device Identification (UDI) Database May 28, 2025 – The Brazilian National Healt…
Read more